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Comparing Cooling and Compression for Chemotherapy-Induced Neuropathy

This study is looking at ways to prevent chemotherapy-induced peripheral neuropathy (CIPN), a nerve problem that can cause numbness, tingling, or pain in your arms and legs. It's often caused by taxane chemotherapy drugs like paclitaxel or docetaxel, which are used to treat solid tumors. Researchers are comparing three different approaches using a device called the Paxman Limb Cryocompression System: cryocompression (cooling and compression), continuous compression, and low cyclic compression. The goal is to see if any of these methods can prevent CIPN. You might be able to join if you have a solid tumor and are about to start one of the specified chemotherapy regimens. The main thing they'll measure is whether you develop CIPN within 12 weeks of starting the study.

Study design
This interventional study plans to enroll 777 participants. It compares three different approaches: cryocompression, continuous compression, and low cyclic compression.
What's involved
You would undergo biospecimen collection (blood, plasma, and serum) and receive either cryocompression, continuous compression, or low cyclic compression therapy. Quality-of-life assessments will also be performed.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at 12 weeks after randomization. Secondary objectives include comparisons over 6, 12, 24, and 52 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05642611

Comparing Cooling and/or Compression Approaches of Limbs for Prevention of Chemotherapy-Induced Peripheral Neuropathy

Recruiting
PHASE3Ages 18+InterventionalPrevention
SWOG Cancer Research Network
~777 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:Biospecimen CollectionCryocompression TherapyPneumatic Compression TherapyQuality-of-Life AssessmentQuestionnaire Administration

At a glance

Recruiting sites
33 of 36 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Occurrence of clinically meaningful chemotherapy induced peripheral neuropathy (CIPN) (binary outcome: yes vs. no)
Measured over At the 12-week assessment after randomization

Conditions

Malignant Solid Neoplasm

Explore related trials

Solid Neoplasm

NCT05642611

Where you'd take part

This study runs at 36 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Baptist Health Lexington

    Lexington, Kentuckystudy coordinator listed

    Recruiting

  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

    Houston, Texasstudy coordinator listed

    Recruiting

  • Bon Secours Saint Francis Medical Center

    Midlothian, Virginiastudy coordinator listed

    Recruiting

  • CaroMont Regional Medical Center

    Gastonia, North Carolinastudy coordinator listed

    Recruiting

  • Cone Health Cancer Center

    Greensboro, North Carolinastudy coordinator listed

    Recruiting

  • Corewell Health Grand Rapids Hospitals - Butterworth Hospital

    Grand Rapids, Michiganstudy coordinator listed

    Recruiting

  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

    Lebanon, New Hampshirestudy coordinator listed

    Recruiting

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Melissa K Accordino · PRINCIPAL_INVESTIGATOR · SWOG - Columbia University
  • Katherine Pennington, MD · PRINCIPAL_INVESTIGATOR · NRG - University of Washington

Who to contact

Justine Trevino
[email protected]
210-614-8808
Email the study team

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Eligibility criteria

Inclusion

Participants must have a diagnosis of a solid tumor malignancy.
Participants must be planning to begin neoadjuvant or adjuvant therapy with one of the protocol-specified chemotherapy regimens below for a solid tumor malignancy within 3 calendar days after randomization.
Weekly paclitaxel x 12 consecutive weeks
Weekly paclitaxel x 12 consecutive weeks + carboplatin (weekly x 12 consecutive weeks or every 3 weeks x 4 consecutive cycles)
Paclitaxel + carboplatin every 3 weeks x 6 consecutive cycles without chemotherapy pause for surgery
Docetaxel + carboplatin every 3 weeks x 6 consecutive cycles without chemotherapy pause for surgery NOTE: For any of the protocol-specified chemotherapy regimens, concurrent targeted therapy with biologic therapy is allowed. Pembrolizumab (or other immune checkpoint inhibitors), trastuzumab and/or pertuzumab, or bevacizumab are allowed.
Participant must be \>= 18 years old.
Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System.
Participants must be able to complete Patient-Reported Outcome (PRO) questionnaires in English or Spanish.
Participants must 1) agree to complete PROs at all scheduled assessments, and 2) complete the baseline PRO questionnaires within 14 days prior to randomization
Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines.

Exclusion

Participants must not have a history of skin or limb metastases.
Participants must not have previously received neurotoxic chemotherapy for any reason (e.g., taxanes, platinum agents, vinca alkaloids, or bortezomib).
Participants must not have pre-existing clinical peripheral neuropathy from any cause.
Participants must not have a history of Raynaud's phenomenon, cold agglutinin disease, cryoglobulinemia, cryofibrinogenemia, post-traumatic cold dystrophy, or peripheral arterial ischemia.
Participants must not have any open skin wounds or ulcers of the limbs at the time of randomization.

What this trial measures

  • Occurrence of clinically meaningful chemotherapy induced peripheral neuropathy (CIPN) (binary outcome: yes vs. no)At the 12-week assessment after randomization

    Defined as an absolute increase of 8 or more points over baseline in the CIPN-20 sensory neuropathy subscale score. Analysis will be conducted multivariable logistic regression, adjusting for the baseline score and the stratification factor as covariates.